Diagnostic package



May 23, 1961 w; N. RElCH DIAGNOSTIC PACKAGE Filed Aug. 10, 1959 INVENTOR. W/LL/AM N. RE/CH /M $2 My) ATTORNEYS DIAGNGSTIC PACKAGE William N. Reich, Walnut Creek, Calili, assignor of one- 5 Claims. or. 206-46) In recent years, with increasing attention to public health, there has developed an increasing need for the rapid and eifective taking of culture samples from large numbers of individuals, keeping such culture samples or specimens in a sterile and segregated way until such time as they can be dispatched to a laboratory for processing, consideration and analysis and so that the individual reports of the resulting individual cultures can be correctly delivered. While there are many fields in which there is a need for such culture sampling and analysis on a very large scale, one representative field is that in which samples apt to contain B-hemolytic streptococci are taken from individuals by means of throat swabs. It is necessary to dispatch each of the cultures so taken to a suitable diagnostic laboratory wherein the swabbed material is cultured and tested for the presence of the particular bacterium. Following this, a suitable report is rendered to the supervising physician. While it is not unduly difficult to accomplish this routine on a single or infrequent samples are not mixed' but can be readily identified and are preserved as to their integrity throughout.

Another object of the inventionis to provide, in general, an improved diagnostic package.

A still further object of the invention is to provide a diagnostic package which can be utilized under generally non-sterile conditions but with the sample itself being retained without extraneous contamination. 7

A further object of the invention is to provide a diagnostic package which is sufiiciently compact and noninfective as to be mailable. V 7

- Other objects, together with the foregoing, are attained in the diagnostic package described in the accompanying description and illustrated in the accompanying drawing, in which: 7 p

Figure 1 is a perspective of a complete diagnostic package in its initial condition.

Figure 2 is an exploded view, with portions being broken away, showing the package partially disassembled and being made ready for use.

Figure 3 is a perspective view showing the insert portion of the package open and being used to receive a sample.

Figure 4 is a perspective, portions being broken away, of a culture plate.

While the diagnostic package can be incorporated or embodied in a number of different ways depending on variations in technique and various surrounding factors, it has quite successfully been utilized as it is disclosed herein. In this instance, there is provided, as shown primarily in Figure 3, an insert including a generally rec- Patented May 23, 1961 tangular sheet 6 of paper-like material. The material is preferably of fibers although it can be cellulose film or the like. Conveniently, it is of a slightly absorbent paper, a material that is somewhat porous in and of itself.

The rectangular sheet is divided by a pair of parallel longitudinal fold lines 7 and 8 and is likewise divided by an intersecting pair of parallel transverse fold lines 9 and 11 so that the sheet is demarked into a central rectangular panel 12, a pair of side panels 13 and 14, a pair of end panels16 and 17 and the remaining corner panels 18, 19,21 and 22.

In accordance with the invention, at least the central panel 12, and preferably also the adjacent side panels 13 and 14 and, if desired, the entire sheet, is provided with a superficial coating, at least on the surface which is uppermost in Figure 3.- This coating is too thin to be illustrated in the drawing but is preferably of a sizing or plastic material or a cover material which is non-porous and is particularly non-absorptive of the sample or swab material which is being dealt with.

Disposed entirely withinthe confines or boundaries of the central panel 12 is a pad 23 of material which is receptive to and preferably at least partly absorptive of the particular sample being utilized. Preferably, the pad 23 is relatively much thicker than the relatively thin material of the sheet 6. The precise nature of the absorptive pad 23 can vary amongst numerous materials but conveniently a high grade filter paper is utilized. Preferably also, the boundaries of the pad 23 are somewhat smaller than those of the central panel to leave surrounding margins. The pad 23 is not only thicker than the supporting material but is also of a somewhat compressible or resilient and spongy nature. v 1

While the coating material for the sheet 6 can itself have some initially adhesive qualities, it is preferred to provide on the-central panel 12 or on the nether side of i the pad 23 an adhesive materialso that when the pad 23 is properly located on the panel 12, it is afiixed thereto or is temporarily secured in place or at least is fairly well secured in place in one or two portions thereof so that it does not dislodge in ordinary handling but can be readily stripped off later on.

For the customary widespread use, it is preferred to provide legends 26 on both surfaces of the side panels 13 and 14 indicating that those panels are sterile and are to be kept so, while additional legends 27 are placed on the end panels 16 and 17 indicating that such panels or tabs or areas are not or need'not be kept sterile.

After the insert has been initially fabricated as described, it is folded first along thelongitudinal lines 7 and 8 so that one or the other of the side panels 13 and 14 is immediately superposed on the pad 23 and the other side panel is then also folded to overlie the central panel. Following this, thecorners 21 and 22 superposed over the end panel 16 are folded over the central panel and the superposed corners 18 and 19, having been folded over the end panel17, are folded along the transverse line 11 to overlie the central panel." The insert so folded is relatively springy, partly due to the nature of the material of which it is fabricated and partly due to the somewhat spongy, relatively thick pad 23, and tends to unfold partially, especially at the end portions.

To preclude premature unfolding and to hold the insert in proper relationship pending use, the folded packet or insert is introduced into an envelope 31 (Figure 1). This is preferably of an inert material, initially open and capable of sterilization so that the entire insert and envelope as a package can be completely sterilized. Following sterilization, one end of the envelope is provided with a seal 32, for example, a heat seal, so that the interior insert or packet can be retained indefinitely without contamination.

When the deviceis to be utilized, one end, for example, the sealed end 312, is opened or a thin end strip is torn from the envelope 31 along the seal line. The open envelope is slightly bulged and the insert is removed by the user grasping the end panel 17and the-subposed portion of the central panel 12. He is assured indoingthis by the legends 27' which appear on the non-sterile por tions and also by avoiding the portions carrying the legends 26' which indicate the interior, sterile portions, having been imprinted on both sides of the unfolded sheet 6. 7

Keeping his hands away from the portions marked sterile, the user unfolds the non-sterile portions substantially to the position shown in Figure 3. This exposes the sterile pad 23; A throat swab is made and the material therefrom is readily rolled upon the pad 23.

The pad'is held firmly in position since it is affixed to the sheet 6 and the sheet is readily held immovable upon the supporting surface by pressure on the non-sterile portions such as 16 and 17.

Following this, the swab is removed and without touching the sterile portions 13 and 14 the user folds the insert again along the fold lines 7 and 8 and again folds over the end panels 16 and'17. The insert is then reintroduced into the open-ended envelope 31. This is a sufficiently tight fit so as to hold the somewhat springy folded ends of the insert in closed condition, thus preventing any contaminating contact With the material on the pad 23. The envelope usually has a suitably prepared area 49 for receipt of the patients name or number by any of the usual writing implements.

In large scale work, a number of filled and marked envelopesare assembled, are further enveloped or packaged and are mailed as a group to the laboratory. At the laboratory, the individual envelopes are opened, the individual inserts are removed and either the pads 23 on the attached sheets 6 are inverted and are individually placed face down on suitable culture media and then removed or the pads 23 are first detached and separately placed on the culture media for a short interval before removal.

A suitable culture plate foithe purpose is illustrated in Figure 4 and includes a dish 41 having partition walls 42 therein defining compartments, such as 43 and- 44, slightly larger than the pads 23. Culture medium is positioned ineach of the compartments 43 and 44. After the individual pads 23 have been contacted with the culture media, a cover 46 is put into positions. Panels 47 on the cover permit; identification'of the culture immediately beneath. After examination of the culture medium following a growth period, the results of the examination are made available 'by name or number to the sending 1 physician.

Pursuant to the invention, there has been provided a diagnostic package which isuseful in individual instances and is especially useful in taking large numbers of cultures, especially inpublic health work, since the package provided can be handled in its'non-sterile portions with out difficulty While preserving the'sterile portions. The package includes an envelopeeifective hold the contained insert closed so that the sample can be mailed.

4 The entire handling is effective topreyent contamination of the sample by outside influences and the escape of any of the sample material.

What is claimed is:

1. A diagnostic package comprising a rectangular sheet of paper-like material having a pair of longitudinal fold lines and a pair of transverse fold lines to divide the sheet into a central "paneland adjacent side, corner and end panels, said adjacent panelsbeing sufiicient in area to cover said central'panel when folded thereover; and a pad of culture-absorbent material directly aifixed to and entirely disposed Within said central panel.

2. A device as in clai'rn'l in which said side panels have a non-absorbent coating on the surfaces contacting said pad when said sheet is folded on said longitudinal fold lines.

3. A diagnostic package comprising a sheet including a panel, a pad of culture-absorbent material affixed to and disposed within the boundaries of said panel, means on said sheet adapted to be folded over into contact with and to cover said pad, said means being non-absorbent to culture on said pad, and means on said sheet constituting non-sterile holding tabs. 7

4. A diagnostic package comprising a rectangular sheet of relatively thin paper-like material having a pair of longitudinal fold lines and a pair of transverse fold lines to divide the sheet into a central panel and adjacent side, corner and end panels; a pad of culture-absorbent material aflixed to and disposed within the boundaries of said central panel, said pad being of relatively thick spongy material whereby when said side panels are folded into superposition on said central panel and pad and said corner and end panels are folded into superposition on said side and central panels, said corner and end panels tend to unfold; and an envelope separate from but closely surroundingsaid folded sheet and said pad and disposed in engagement with said foldedcorner and end panels to prevent unfolding thereof.

5. A diagnostic package comprising a rectangular sheet of paper-like material having a coating non-absorbent to culture on one side thereof and having a pair of parallel longitudinal fold lines and a' pair of parallel transverse fold lines to divide said sheet into a central panel and side, end and corner panels, said side, end and corner,

panels when folded being effective to cover said central panel with the coating thereon facing the coating on said panel; a rectangular pad of culture-absorbent material enclosed by said coating and disposed on' and entirely, within said central panel; and means for affixing said pad to said sheet in direct contact therewith. 

